Events

Rappel de Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an endoscope, for diagnostic and/or operative endoscopy)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ConMed Linvatec Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01601-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-12-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01601-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    The reason for this recall is that the device could cause a patient overpressure situation without any visual or auditory indication or warning from the device. if specific conditions occur, the affected unit could create an overpressure which is transient and reversible, requiring intervention from medical staff. if the device were to fail, the surgical attendants, anaesthetist or doctor would see an over -distension of the pneumoperitoneum or difficulty in patient breathing. the manufacturer has received one adverse event report overseas where the device caused an overpressure situation.
  • Action
    Conmed is advising users to immediately check their facility for the affected unit(s) and to contact Conmed, who will in turn organise collection of the affected unit and return of the corrected unit. If necessary, Conmed will provide a loaner device whilst the product correction is undertaken.

Device

Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an...
  • Modèle / numéro de série
    Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an endoscope, for diagnostic and/or operative endoscopy)Affected Serial Numbers: 90869KZD and 91114CADARTG Number: 233786
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd